Brief Title
Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy
Official Title
Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy
Brief Summary
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.
Detailed Description
To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.
Study Type
Observational
Primary Outcome
the highest grade of oral mucositis
Condition
Nasopharyngeal Carcinoma
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
September 1, 2016
Completion Date
January 31, 2019
Primary Completion Date
November 30, 2018
Eligibility Criteria
Inclusion Criteria: 1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group. 5.Adequate bone marrow, renal, and hepatic function. Exclusion Criteria: 1. Treatment with palliative intent. 2. Previous malignancy. 3. Pregnancy or lactation. 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes. 5. Any severe coexisting disease.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yuanyuan Chen, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03647527
Organization ID
PF-AROM-NPC-IMRT/TOMO
Responsible Party
Principal Investigator
Study Sponsor
Zhejiang Cancer Hospital
Study Sponsor
Yuanyuan Chen, Principal Investigator, Zhejiang Cancer Hospital
Verification Date
August 2018